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San Diego, CA | March 21 – 22, 2019

Richmond, VA | April 11 – 12, 2019

Seminar DescriptionAgendaSpeakerPricingVenue

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used to support clinical trials. These include clinical trial data collection, management and reporting systems, clinical trial sample manufacturing, testing and labeling systems, and all of those systems used in the conduct of the clinical trial which generate documentation for the clinical Trial Master File (TMF).

Why You Should Attend:

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of clinical trials and determining the level of compliance, based on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential clinical trial files that must be maintained before, during and after completion of the trial in the Trial Master File (TMF). This part of the discussion will also delve into the use of electronic Trial Master File (eTMF) systems and the pros and cons of doing so.

Finally, we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials. These are extremely valuable assets for any company doing this type of work, and best efforts are necessary to ensure data is maintained in a state of integrity throughout its lifecycle.

Areas Covered in the Session :

Learn how to identify “GxP” Systems

Discuss the Computer System Validation (CSV) approach based on FDA requirements

Learn about the System Development Life Cycle (SDLC) approach to validation

Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures

Understand how to maintain a system in a validated state through the system’s entire life cycle

Learn how to assure the integrity of clinical data that supports trial work

Discuss the importance of “GxP” documentation that complies with FDA requirements

Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state

Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures

Know the regulatory influences that lead to FDA’s current thinking at any given time

Know the clinical data files that are essential to collect before, during and after the conduct of a trial

Learn how to best prepare for an FDA inspection or audit of a clinical trial related computer system

Who Should Attend :

This seminar is intended for those involved in clinical trial planning, execution and support, working in the FDA-regulated industries, including pharmaceutical, medical device, biological and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, clinical sample labeling, adverse events management and post-marketing surveillance.

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that is used to conduct, manage or support the conduct of clinical trials, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

Clinical Data Analysts

Clinical Data Managers

Clinical Trial Sponsors

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Analytical Chemists

Compliance and Audit Managers

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

This seminar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Carolyn Troiano

CSV Consultant

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Terms & Conditions to Register for the Seminar

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a $300 administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

Once we receive the check, you will be receiving a Form to fill up the Delegates Information

After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

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Refund Policy

Webinar Compliance reserves the right to cancel or reschedule any Webinar/event due to inevitable reasons such as insufficient registrations or circumstances beyond its control. All the attendees will be notified about the cancellation of the event, 24 hours prior to the start time of the Webinar event.

The cancelled Webinar, could be rescheduled and a New Date would be promptly intimated to the attendees.

In such an event, the attendee can opt for one of the below :

If the New Date is not of convenience, the webinar stream (1-Time Recording) may be availed.

The attendees may also opt to take a different webinar, which has a same price tag at a future date & time; they are welcome to do so.

On-Demand recordings (Past events) in exchange but equal to the original amount remitted.

A redeemable voucher (Valid for 12 months), which could be used to purchase any of our future events.

Webinar Compliance will process refund only if an event that has been cancelled, is not rescheduled within 90 days from the original scheduled date of the webinar.

If a webinar is canceled completely, an attendee may opt either of above points 2,3,4, or a full refund of the amount paid in a single settlement. The payment will be processed within 7 Business days from the day, we receive the refund request. However, Webinar Compliance will not be responsible for any penalties or other expenditure incurred due to the cancellation.

​Individual attendees can cancel their event for any specific reason. They must notify Webinar Compliance about the cancellation of their registration at least 48 hours prior to the event start date and time.

If the attendee fails to cancel the registration to the event within the above mentioned stipulated time or if fails to attend the event, no refund shall be made.

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​For further clarification on the refund or cancellation policy, you can contact the support team over the phone or please write to us on support@webinarcompliance.com, with the transaction ID, event ID & event date in the subject column.